Energy based hyperhidrosis treatment

ABSTRACT

A method and system for energy-based (e.g., ultrasound treatment and/or other modalities) of sweat glands are provided. An exemplary method and system for targeted treatment of sweat glands can be configured in various manners, such as through use of therapy only, therapy and monitoring, imaging and therapy, or therapy, imaging, and monitoring, and/or through use of focused, unfocused, or defocused ultrasound (or other energy) through control of various spatial and temporal parameters. As a result, ablative energy can be deposited at the particular depth at which the aberrant sweat gland population is located below the skin surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/571,835 filed on Dec. 16, 2014, issued as U.S. Pat. No. 9,421,029,which is a continuation of U.S. application Ser. No. 13/950,728 filed onJul. 25, 2013, issued as U.S. Pat. No. 8,932,224, which is acontinuation of U.S. application Ser. No. 13/603,279 filed on Sep. 4,2012, issued as U.S. Pat. No. 8,523,775, which is a continuation of U.S.application Ser. No. 13/444,485 filed on Apr. 11, 2012, issued as U.S.Pat. No. 8,282,554, which is a continuation of U.S. application Ser. No.11/163,152 filed on Oct. 6, 2005, now abandoned, which claims thebenefit of priority to U.S. Provisional Application No. 60/616,752,filed on Oct. 6, 2004, each of which is incorporated in its entirety byreference herein. Any and all priority claims identified in theApplication Data Sheet, or any correction thereto, are herebyincorporated by reference under 37 CFR 1.57.

BACKGROUND

1. Field of the Invention

This invention generally relates to a therapeutic ultrasound method andsystem, and more particularly, to a method and system for ultrasoundtreatment for superficial tissue containing sweat glands.

2. Description of the Related Art

The sweat glands in the body are of divided into apocrine and eccrineglands. Apocrine glands are similar to sebaceous glands, and are presentmainly in the axillae. These glands, like sebaceous glands, secrete anoily proteinaceous product into the follicles. Bacterial digestion ofapocrine sweat is largely responsible for underarm “body odor”.Similarly, eccrine sweat glands are present deep in the dermis in thepalms, soles and armpits and are responsible for temperature regulationresulting from sweating. Excessive activity of these glands also resultsin copious amounts of abnormal sweating (“hyperhidrosis”), primarilyunder autonomic neuronal control. Reduction of sweating from under thearmpits and other regions is a particularly desirable effect within themodern society. Presently, chemical antiperspirants and deodorants areused frequently as a matter of personal hygiene. Antiperspirants arealuminum based salts that block the sweat gland ducts. The deodorantchanges the pH of the skin milieu thereby minimizing the presence of(smell inducing) bacteria. The effects with both these componentshowever, are temporary and these chemicals are known to irritate theskin in a good percentage of users.

Further, there is currently a significant unmet need in managing theexcessive sweating and concomitant issues with odor as a result ofHydradenitis suppurativa (irritable infected armpit). This acne-likeprocess in apocine follicles also causes hydradenitis suppurativa, whichis often a devastating condition in which very painful cysts andscarring occurs repeatedly in the axillae. The etiology (causes) of thisclinical condition is not well understood. However, there are a numberof marginally effective approaches to manage this condition. Retinoiddrug therapy works marginally but is associated with severe toxicity.Some prescription formulations of antiperspirants can be used, but theyare not particularly effective. These preparations can be applied withthe addition of an iontophoretic device. This technique however, is notknown to be any more effective than the formulation. The sweat glandscan be surgically removed from the armpits and/or the sympathetic nervesupply can be interrupted surgically. This approach is fraught with itsown drawbacks in terms of morbidity, scarring and cost. BOTOX® is beingused ever more for paralyzing the nerve connections that induceexcessive sweating in the armpits. However, this is a new approach yetto be completely validated. This technique requires multiple injections(painful) and the results last a few months only (3-4 months), henceneed to be repeated. This technique does not get rid of the odorassociated with the condition.

SUMMARY OF THE INVENTION

The present invention describes a non-invasive method and system forusing therapeutic ultrasound energy for the treatment of conditionsresulting from sweat gland disorders. An ultrasound system and methodcomprises a transducer probe and control system configured to deliverultrasound energy to the regions of the superficial tissue (e.g., skin)such that the energy can be deposited at the particular depth at whichthe aberrant sweat gland population is located below the skin surface.

In accordance with various exemplary embodiments, the ultrasoundtransducer can be driven at a number of different frequency regimes suchthat the depth and shape of energy concentration can match the region oftreatment. In addition, the ultrasound source or beam radiated from thetransducer can be highly focused, weakly focused, or divergent, each ina cylindrical or spherical geometric configuration, and/or can also beplanar to radiate a directive beam through the tissue, or various otherconfigurations. Further, the ultrasound field can be varied spatiallyand temporally in a suitable manner to achieve the optimal tissue effectand/or type of conformal lesion for treating the sweat glands.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of the invention is particularly pointed out in theconcluding portion of the specification. The invention, however, both asto organization and method of operation, may best be understood byreference to the following description taken in conjunction with theaccompanying drawing figures, in which like parts may be referred to bylike numerals:

FIG. 1 illustrates a block diagram of an ultrasound therapy system fortreating sweat glands in accordance with an exemplary embodiment of thepresent invention;

FIG. 2A and 2B illustrate schematic diagrams of ultrasound treatmentsystems configured to treat the sweat glands via direct targeting ofheating and damage within the treatment layer in accordance with variousexemplary embodiments of the present invention;

FIGS. 3A and 3B illustrate block diagrams of an exemplary control systemin accordance with exemplary embodiments of the present invention;

FIGS. 4A and 4B illustrate block diagrams of an exemplary probe systemin accordance with exemplary embodiments of the present invention;

FIG. 5 illustrates a cross-sectional diagram of an exemplary transducerin accordance with an exemplary embodiment of the present invention;

FIGS. 6A and 6B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with exemplary embodiments of the presentinvention;

FIG. 7 illustrates exemplary transducer configurations for ultrasoundtreatment in accordance with various exemplary embodiments of thepresent invention;

FIGS. 8A and 8B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with another exemplary embodiment of thepresent invention;

FIG. 9 illustrates an exemplary transducer configured as atwo-dimensional array for ultrasound treatment in accordance with anexemplary embodiment of the present invention;

FIGS. 10A-10F illustrate cross-sectional diagrams of exemplarytransducers in accordance with other exemplary embodiments of thepresent invention;

FIG. 11 illustrates a schematic diagram of an acoustic coupling andcooling system in accordance with an exemplary embodiment of the presentinvention;

FIG. 12 illustrates a block diagram of an ultrasound treatment systemcombined with additional subsystems and methods of treatment monitoringand/or treatment imaging as well as a secondary treatment subsystem inaccordance with an exemplary embodiment of the present invention; and

FIG. 13 illustrates a schematic diagram with imaging, therapy, ormonitoring being provided with one or more active or passive oralinserts in accordance with an exemplary embodiment of the presentinvention.

DETAILED DESCRIPTION

The present invention may be described herein in terms of variouscomponents and processing steps. It should be appreciated that suchcomponents and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,the present invention may be configured with various medical treatmentdevices, visual imaging and display devices, input terminals and thelike, which may carry out a variety of functions under the control ofone or more control systems or other control devices. In addition, thepresent invention may be practiced in any number of medical or treatmentcontexts and that the exemplary embodiments relating to a method andsystem for sweat gland treatment as described herein are merely a few ofthe exemplary applications for the invention. For example, theprinciples, features and methods discussed may be applied to any medicalor other tissue or treatment application.

In accordance with various aspects of the present invention, anon-invasive method and system for the treatment of sweat glands isdescribed. In accordance with an exemplary embodiment, an ultrasoundtransducer probe and control system are configured to deliver ultrasoundenergy to a targeted/specified depth and zone where the sweat glandpopulation is required to be treated. The ultrasound beam from thetransducer probe can be spatially and/or temporally adjusted, modifiedor otherwise controlled to match the adequate treatment of the sweatglands in the region of interest.

For example, in accordance with an exemplary embodiment, with referenceto FIG. 1, an exemplary treatment system 100 configured to treat aregion of interest (ROI) 106 comprises a control system 102, animaging/therapy probe with acoustic coupling 104, and a display system108.

Control system 102 and display 108 can comprise various configurationsfor controlling functionality of probe 104 and system 100, including forexample a microprocessor with software and a plurality of input/outputand communication devices, a system for controlling electronic and/ormechanical scanning and/or multiplexing of transducers, a system forpower delivery, systems for monitoring, systems for sensing the spatialparameters and/or temporal parameters of the probe and transducers,and/or systems for handling user input and recording treatment input andresults, among others. Imaging/therapy probe 104 can comprise variousprobe and/or transducer configurations. For example, probe 104 can beconfigured for a combined dual-mode imaging/therapy transducer, coupledor co-housed imaging/therapy transducers, a separate therapy probe andseparate imaging probe, or a single therapy probe. In accordance withexemplary embodiments, imaging transducers may operate at frequenciesfrom approximately 2 MHz to 75 MHz or more, while therapy energy can bedelivered at frequencies from approximately 500 kHz to 15 MHz, with 2MHz to 25 MHz being typical.

With reference to FIG. 2A, sweat glands 230 are generally located withina dermis layer 214 at a depth close to hair bulbs 236. In order to treatsweat glands that require treatment in particular anatomical sites, suchas, for example but not limited to, the axillary region (armpit), thepalms and soles, an ultrasound transducer probe can be coupled to theskin tissue using one of the numerous coupling media, such as water,mineral oils, gels, and the like.

For example, with reference to FIG. 2B, in accordance with an exemplaryembodiment an exemplary treatment method and system are configured forinitially imaging a region 222 within a region of interest 206 anddisplaying that region 224 on a display 208 to facilitate localizationof the treatment area and surrounding structures, e.g., identificationof sweat glands 230, such as within the axillary region (armpit), thepalms and soles or any other tissue or skin surrounding sweat glands.After localization, delivery of ultrasound energy 220 at a depth,distribution, timing, and energy level to achieve the desiredtherapeutic effect of thermal ablation to treat a sweat gland 230 isprovided. Before, during, and/or after therapy, i.e., before, duringand/or after delivery of ultrasound energy, monitoring of the treatmentarea and surrounding structures can be conducted to further planning andassessing of the results and/or providing feedback to control system 202and a system operator.

In accordance with an exemplary embodiment, localization can befacilitated through ultrasound imaging that can be used to define theposition of a sweat gland 230 and/or the depth of sweat glands 230 overa region of interest before depositing in a defined pattern at a targetregion 220. Such glands can be seen lying along hair follicles 232 andbulbs 236 and their image may be further enhanced via signal and imageprocessing. Ultrasound imaging can also be used for safety purposes,namely, to avoid injuring vital structures, such as nerve endings 240.In accordance with other exemplary embodiments, localization can also beaccomplished without imaging region 222, but instead can be based onprior known depths of sweat glands or other target regions, and thus beconfigured geometrically and/or electronically to selectively depositenergy at a particular known depth below skin surface 210 to a targetregion 220.

The ultrasound beam from probe 204 can be spatially and/or temporallycontrolled by changing the spatial parameters of the transducer, such asthe placement, distance, treatment depth and transducer structure, aswell as by changing the temporal parameters of transducer, such as thefrequency, drive amplitude, and timing, with such control handled viacontrol system 202. For example, in some applications, the temporalenergy exposure at one location may range from approximately to 40 ms to40 seconds, while the corresponding source frequency can suitably rangefrom approximately 500 kHz to 15 MHz. Such spatial and temporalparameters can also be suitably monitored and/or utilized in open-loopand/or closed-loop feedback systems within treatment system 200. As aresult of such spatial and/or temporal control, conformal lesions ofvarious, specifically targeted, shapes, sizes and orientations can beconfigured within target region 220.

In accordance with an exemplary embodiment, the treatment resulting fromultrasound energy delivery in the region of sweat glands 230 can be usedto achieve selective ablation of regions of sub-epidermal region (0.5-10mm diameter zones). For example, one or more treated zones 242 can beconfigured to produce regions of ablative damage in spatially definedpatterns, such as a discrete locus of spaced treatment spots or two- orthree-dimensional matrix of damage or destroyed tissue, e.g., a matrixof cross-stitched, ellipsoidal/cigar-shaped, wedge-shaped,mushroom-shaped or any other conformal lesions, rather than heating anddestroying the entire volume of the target layer of tissue. In such atreatment where surrounding regions are spared of damage, thesurrounding undamaged tissue aids rapid healing and recovery.

In accordance with another exemplary embodiment, a whole contiguoussheet of treatment area can be achieved, whereby all the sweat glandswithin the said area are ablated. In addition to selective treatment ofsweat gland regions, in accordance with another exemplary embodiment,treatment system 200 could be configured to “carpet bomb” the fat layerat 1-7 mm depth, e.g., up to 90% of the sweat glands in the armpit canbe ablated without any physiologic issues.

In accordance with another exemplary embodiment of the presentinvention, an exemplary monitoring method may comprise monitoring thetemperature profile or other tissue parameters of the region of interest206, such as attenuation, speed of sound, or mechanical properties suchas stiffness and strain of the treatment region and suitably adjust thespatial and/or temporal characteristics and energy levels of theultrasound therapy transducer of probe 204. The results of suchmonitoring techniques may be indicated on display 208 by means of one-,two-, or three-dimensional images of monitoring results 250, or maysimply comprise a success or fail-type indicator 252, or combinationsthereof. Additional treatment monitoring techniques may be based on oneor more of temperature, video, profilometry, and/or stiffness or straingauges or any other suitable sensing technique.

The non-thermal effects from an acoustic field can also “shock” thesweat producing apocrine and eccrine cells in to reduced activity. Theseeffects mentioned here as examples are, but not limited to, acousticcavitation, acoustic streaming, inter-cellular shear effects, cellresonant effects, and the like.

In accordance with an exemplary embodiment, focused or directiveultrasound energy can be used for the treatment of sweat glands in thearmpit (without the combination of pharmacological formulations). Forexample, a clinical indication would be to use in the management ofHidradenitis suppurativa. Ultrasound energy deposited at a selectivedepth can also be used in combination with a number of pharmaceuticalformulations that are currently prescribed for the treatment of sweatgland hyperactivity in the axillary region, palms and soles. Theultrasound energy delivered to the target region in combination with thepharmaceutical agents such as BOTOX® or retinoids can helpsynergistically treat the sweat gland region by, (1) increasing activityof the agents due to the thermal and non-thermal mechanisms, (2) reducedrequirement of overall drug dosage, as well as reducing the drugtoxicity, (3) increase local effect of drug in a site selective manner.

An exemplary control system 202 and display system 208 may be configuredin various manners for controlling probe and system functionality forproviding the various exemplary treatment methods illustrated above. Forexample, with reference to FIGS. 3A and 3B, in accordance with exemplaryembodiments, an exemplary control system 300 can be configured forcoordination and control of the entire therapeutic treatment process toachieve the desired therapeutic effect of thermal ablation to treat asweat gland. For example, control system 300 can suitably comprise powersource components 302, sensing and monitoring components 304, coolingand coupling controls 306, and/or processing and control logiccomponents 308. Control system 300 can be configured and optimized in avariety of ways with more or less subsystems and components to implementthe therapeutic system for controlled thermal injury of sweat glands,and the embodiments in FIGS. 3A and 3B are merely for illustrationpurposes.

For example, for power sourcing components 302, control system 300 cancomprise one or more direct current (DC) power supplies 303 configuredto provide electrical energy for entire control system 300, includingpower required by a transducer electronic amplifier/driver 312. A DCcurrent sense device 305 can also be provided to confirm the level ofpower going into amplifiers/drivers 312 for safety and monitoringpurposes.

Amplifiers/drivers 312 can comprise multi-channel or single channelpower amplifiers and/or drivers. In accordance with an exemplaryembodiment for transducer array configurations, amplifiers/drivers 312can also be configured with a beamformer to facilitate array focusing.An exemplary beamformer can be electrically excited by anoscillator/digitally controlled waveform synthesizer 310 with relatedswitching logic.

The power sourcing components can also include various filteringconfigurations 314. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 312 to increasethe drive efficiency and effectiveness. Power detection components 316may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 316may be used to monitor the amount of power going to an exemplary probesystem.

Various sensing and monitoring components 304 may also be suitablyimplemented within control system 300. For example, in accordance withan exemplary embodiment, monitoring, sensing and interface controlcomponents 324 may be configured to operate with various motiondetection systems implemented within transducer probe 204 to receive andprocess information such as acoustic or other spatial and temporalinformation from a region of interest. Sensing and monitoring componentscan also include various controls, interfacing and switches 309 and/orpower detectors 316. Such sensing and monitoring components 304 canfacilitate open-loop and/or closed-loop feedback systems withintreatment system 200.

Cooling/coupling control systems 306 may be provided to remove wasteheat from an exemplary probe 204, provide a controlled temperature atthe superficial tissue interface and deeper into tissue, and/or provideacoustic coupling from transducer probe 204 to region-of-interest 206.Such cooling/coupling control systems 306 can also be configured tooperate in both open-loop and/or closed-loop feedback arrangements withvarious coupling and feedback components.

Processing and control logic components 308 can comprise various systemprocessors and digital control logic 307, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays(FPGAs), computer boards, and associated components, including firmwareand control software 326, which interfaces to user controls andinterfacing circuits as well as input/output circuits and systems forcommunications, displays, interfacing, storage, documentation, and otheruseful functions. System software and firmware 326 controls allinitialization, timing, level setting, monitoring, safety monitoring,and all other system functions required to accomplish user-definedtreatment objectives. Further, various control switches 308 can also besuitably configured to control operation.

An exemplary transducer probe 204 can also be configured in variousmanners and comprise a number of reusable and/or disposable componentsand parts in various embodiments to facilitate its operation. Forexample, transducer probe 204 can be configured within any type oftransducer probe housing or arrangement for facilitating the coupling oftransducer to a tissue interface, with such housing comprising variousshapes, contours and configurations. Transducer probe 204 can compriseany type of matching, such as for example, electric matching, which maybe electrically switchable; multiplexer circuits and/or aperture/elementselection circuits; and/or probe identification devices, to certifyprobe handle, electric matching, transducer usage history andcalibration, such as one or more serial EEPROM (memories). Transducerprobe 204 may also comprise cables and connectors; motion mechanisms,motion sensors and encoders; thermal monitoring sensors; and/or usercontrol and status related switches, and indicators such as LEDs. Forexample, a motion mechanism in probe 204 may be used to controllablycreate multiple lesions, or sensing of probe motion itself may be usedto controllably create multiple lesions and/or stop creation of lesions,e.g. for safety reasons if probe 204 is suddenly jerked or is dropped.In addition, an external motion encoder arm may be used to hold theprobe during use, whereby the spatial position and attitude of probe 104is sent to the control system to help controllably create lesions.Furthermore, other sensing functionality such as profilometers or otherimaging modalities may be integrated into the probe in accordance withvarious exemplary embodiments.

With reference to FIGS. 4A and 4B, in accordance with an exemplaryembodiment, a transducer probe 400 can comprise a control interface 402,a transducer 404, coupling components 406, and monitoring/sensingcomponents 408, and/or motion mechanism 410. However, transducer probe400 can be configured and optimized in a variety of ways with more orless parts and components to provide treatment of sweat glands, and theembodiments in FIGS. 4A and 4B are merely for illustration purposes.

Control interface 402 is configured for interfacing with control system300 to facilitate control of transducer probe 400. Control interfacecomponents 402 can comprise multiplexer/aperture select 424, switchableelectric matching networks 426, serial EEPROMs and/or other processingcomponents and matching and probe usage information 430, cable 428 andinterface connectors 432.

Coupling components 406 can comprise various devices to facilitatecoupling of transducer probe 400 to a region of interest. For example,coupling components 406 can comprise cooling and acoustic couplingsystem 420 configured for acoustic coupling of ultrasound energy andsignals. Acoustic cooling/coupling system 420 with possible connectionssuch as manifolds may be utilized to couple sound into theregion-of-interest, control temperature at the interface and deeper intotissue, provide liquid-filled lens focusing, and/or to remove transducerwaste heat. Coupling system 420 may facilitate such coupling through useof various coupling mediums, including air and other gases, water andother fluids, gels, solids, and/or any combination thereof, or any othermedium that allows for signals to be transmitted between transduceractive elements 412 and a region of interest. In addition to providing acoupling function, in accordance with an exemplary embodiment, couplingsystem 420 can also be configured for providing temperature controlduring the treatment application. For example, coupling system 420 canbe configured for controlled cooling of an interface surface or regionbetween transducer probe 400 and a region of interest and beyond bysuitably controlling the temperature of the coupling medium. Thesuitable temperature for such coupling medium can be achieved in variousmanners, and utilize various feedback systems, such as thermocouples,thermistors or any other device or system configured for temperaturemeasurement of a coupling medium. Such controlled cooling can beconfigured to further facilitate spatial and/or thermal energy controlof transducer probe 400.

In accordance with an exemplary embodiment, with additional reference toFIG. 11, acoustic coupling and cooling 1140 can be provided toacoustically couple energy and imaging signals from transducer probe1104 to and from the region of interest 1106 and deeper into tissue, toprovide thermal control at the probe 1100 to region-of-interestinterface (skin) 1110, and to remove potential waste heat from thetransducer probe at region 1144.

Temperature monitoring can be provided at the coupling interface via athermal sensor 1146 to provide a mechanism of temperature measurement1148 and control via control system 1102 and a thermal control system1142. Thermal control may consist of passive cooling such as via heatsinks or natural conduction and convection or via active cooling such aswith peltier thermoelectric coolers, refrigerants, or fluid-basedsystems comprised of pump, fluid reservoir, bubble detection, flowsensor, flow channels/tubing 1144 and thermal control 1142.

With continued reference to FIG. 4, monitoring and sensing components408 can comprise various motion and/or position sensors 416, temperaturemonitoring sensors 418, user control and feedback switches 414 and otherlike components for facilitating control by control system 300, e.g., tofacilitate spatial and/or temporal control through open-loop andclosed-loop feedback arrangements that monitor various spatial andtemporal characteristics.

Motion mechanism 410 can comprise manual operation, mechanicalarrangements, or some combination thereof. For example, a motionmechanism driver 322 can be suitably controlled by control system 300,such as through the use of accelerometers, encoders or otherposition/orientation devices 416 to determine and enable movement andpositions of transducer probe 400. Linear, rotational or variablemovement can be facilitated, e.g., those depending on the treatmentapplication and tissue contour surface.

Transducer 404 can comprise one or more transducers configured fortreating of sweat glands and targeted regions. Transducer 404 can alsocomprise one or more transduction elements and/or lenses 412. Thetransduction elements can comprise a piezoelectrically active material,such as lead zirconate titanate (PZT), or any other piezoelectricallyactive material, such as a piezoelectric ceramic, crystal, plastic,and/or composite materials, as well as lithium niobate, lead titanate,barium titanate, and/or lead metaniobate. In addition to, or instead of,a piezoelectrically active material, transducer 404 can comprise anyother materials configured for generating radiation and/or acousticalenergy. Transducer 404 can also comprise one or more matching layersconfigured along with the transduction element such as coupled to thepiezoelectrically active material. Acoustic matching layers and/ordamping may be employed as necessary to achieve the desiredelectroacoustic response.

In accordance with an exemplary embodiment, the thickness of thetransduction element of transducer 404 can be configured to be uniform.That is, a transduction element 412 can be configured to have athickness that is substantially the same throughout. In accordance withanother exemplary embodiment, the thickness of a transduction element412 can also be configured to be variable. For example, transductionelement(s) 412 of transducer 404 can be configured to have a firstthickness selected to provide a center operating frequency ofapproximately 2 kHz to 75 MHz, such as for imaging applications.Transduction element 412 can also be configured with a second thicknessselected to provide a center operating frequency of approximately 2 to50 MHz, and typically between 2 MHz and 25 MHz for therapy application.Transducer 404 can be configured as a single broadband transducerexcited with at least two or more frequencies to provide an adequateoutput for generating a desired response. Transducer 404 can also beconfigured as two or more individual transducers, wherein eachtransducer comprises one or more transduction element. The thickness ofthe transduction elements can be configured to provide center-operatingfrequencies in a desired treatment range.

Transducer 404 may be composed of one or more individual transducers inany combination of focused, planar, or unfocused single-element,multi-element, or array transducers, including 1-D, 2-D, and annulararrays; linear, curvilinear, sector, or spherical arrays; spherically,cylindrically, and/or electronically focused, defocused, and/or lensedsources. For example, with reference to an exemplary embodiment depictedin FIG. 5, transducer 500 can be configured as an acoustic array 502 tofacilitate phase focusing. That is, transducer 500 can be configured asan array of electronic apertures that may be operated by a variety ofphases via variable electronic time delays. By the term “operated,” theelectronic apertures of transducer 500 may be manipulated, driven, used,and/or configured to produce and/or deliver an energy beam correspondingto the phase variation caused by the electronic time delay. For example,these phase variations can be used to deliver defocused beams 508,planar beams 504, and/or focused beams 506, each of which may be used incombination to achieve different physiological effects in a region ofinterest 510. Transducer 500 may additionally comprise any softwareand/or other hardware for generating, producing and/or driving a phasedaperture array with one or more electronic time delays.

Transducer 500 can also be configured to provide focused treatment toone or more regions of interest using various frequencies. In order toprovide focused treatment, transducer 500 can be configured with one ormore variable depth devices to facilitate treatment. For example,transducer 500 may be configured with variable depth devices disclosedin U.S. patent application Ser. No. 10/944,500, entitled “System andMethod for Variable Depth Ultrasound”, filed on Sep. 16, 2004, having atleast one common inventor and a common Assignee as the presentapplication, and incorporated herein by reference. In addition,transducer 500 can also be configured to treat one or more additionalROI 510 through the enabling of sub-harmonics or pulse-echo imaging, asdisclosed in U.S. patent application Ser. No. 10/944,499, entitled“Method and System for Ultrasound Treatment with a Multi-directionalTransducer”, filed on Sep. 16, 2004, having at least one common inventorand a common Assignee as the present application, and also incorporatedherein by reference.

Moreover, any variety of mechanical lenses or variable focus lenses,e.g. liquid-filled lenses, may also be used to focus and/or defocus thesound field. For example, with reference to exemplary embodimentsdepicted in FIGS. 6A and 6B, transducer 600 may also be configured withan electronic focusing array 602 in combination with one or moretransduction elements 606 to facilitate increased flexibility intreating ROI 610. Array 602 may be configured in a manner similar totransducer 502. That is, array 602 can be configured as an array ofelectronic apertures that may be operated by a variety of phases viavariable electronic time delays, for example, T1, T2 . . . Tj. By theterm “operated,” the electronic apertures of array 602 may bemanipulated, driven, used, and/or configured to produce and/or deliverenergy in a manner corresponding to the phase variation caused by theelectronic time delay. For example, these phase variations can be usedto deliver defocused beams, planar beams, and/or focused beams, each ofwhich may be used in combination to achieve different physiologicaleffects in ROI 610.

Transduction elements 606 may be configured to be concave, convex,and/or planar. For example, in an exemplary embodiment depicted in FIG.6A, transduction elements 606 are configured to be concave in order toprovide focused energy for treatment of ROI 610. Additional embodimentsare disclosed in U.S. patent application Ser. No. 10/944,500, entitled“Variable Depth Transducer System and Method”, and again incorporatedherein by reference.

In another exemplary embodiment, depicted in FIG. 6B, transductionelements 606 can be configured to be substantially flat in order toprovide substantially uniform energy to ROI 610. While FIGS. 6A and 6Bdepict exemplary embodiments with transduction elements 604 configuredas concave and substantially flat, respectively, transduction elements604 can be configured to be concave, convex, and/or substantially flat.In addition, transduction elements 604 can be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element can be configured to beconcave, while a second transduction element can be configured to besubstantially flat.

With reference to FIGS. 8A and 8B, transducer 800 can be configured assingle-element arrays, wherein a single-element 802, e.g., atransduction element of various structures and materials, can beconfigured with a plurality of masks 804, such masks comprising ceramic,metal or any other material or structure for masking or altering energydistribution from element 802, creating an array of energy distributions808. Masks 804 can be coupled directly to element 802 or separated by astandoff 806, such as any suitably solid or liquid material.

An exemplary transducer 404 can also be configured as an annular arrayto provide planar, focused and/or defocused acoustical energy. Forexample, with reference to FIGS. 10A and 10B, in accordance with anexemplary embodiment, an annular array 1000 can comprise a plurality ofrings 1012, 1014, 1016 to N. Rings 1012, 1014, 1016 to N can bemechanically and electrically isolated into a set of individualelements, and can create planar, focused, or defocused waves. Forexample, such waves can be centered on-axis, such as by methods ofadjusting corresponding transmit and/or receive delays, τ1, τ2, τ3 . . .τN. An electronic focus 1020 can be suitably moved along various depthpositions, and can enable variable strength or beam tightness, while anelectronic defocus can have varying amounts of defocusing. In accordancewith an exemplary embodiment, a lens and/or convex or concave shapedannular array 1000 can also be provided to aid focusing or defocusingsuch that any time differential delays can be reduced. Movement ofannular array 800 in one, two or three-dimensions, or along any path,such as through use of probes and/or any conventional robotic armmechanisms, may be implemented to scan and/or treat a volume or anycorresponding space within a region of interest.

Transducer 404 can also be configured in other annular or non-arrayconfigurations for imaging/therapy functions. For example, withreference to FIGS. 10C-10F, a transducer can comprise an imaging element1012 configured with therapy element(s) 1014. Elements 1012 and 1014 cancomprise a single-transduction element, e.g., a combinedimaging/transducer element, or separate elements, can be electricallyisolated 1022 within the same transduction element or between separateimaging and therapy elements, and/or can comprise standoff 1024 or othermatching layers, or any combination thereof. For example, withparticular reference to FIG. 10F, a transducer can comprise an imagingelement 1012 having a surface 1028 configured for focusing, defocusingor planar energy distribution, with therapy elements 1014 including astepped-configuration lens configured for focusing, defocusing, orplanar energy distribution.

In accordance with various exemplary embodiments of the presentinvention, transducer 404 may be configured to provide one, two and/orthree-dimensional treatment applications for focusing acoustic energy toone or more regions of interest. For example, as discussed above,transducer 404 can be suitably diced to form a one-dimensional array,e.g., transducer 602 comprising a single array of sub-transductionelements.

In accordance with another exemplary embodiment, transducer 404 may besuitably diced in two-dimensions to form a two-dimensional array. Forexample, with reference to FIG. 9, an exemplary two-dimensional array900 can be suitably diced into a plurality of two-dimensional portions902. Two-dimensional portions 902 can be suitably configured to focus onthe treatment region at a certain depth, and thus provide respectiveslices 904, 907 of the treatment region. As a result, thetwo-dimensional array 900 can provide a two-dimensional slicing of theimage place of a treatment region, thus providing two-dimensionaltreatment.

In accordance with another exemplary embodiment, transducer 404 may besuitably configured to provide three-dimensional treatment. For example,to provide-three dimensional treatment of a region of interest, withreference again to FIG. 1, a three-dimensional system can comprise atransducer within probe 104 configured with an adaptive algorithm, suchas, for example, one utilizing three-dimensional graphic software,contained in a control system, such as control system 102. The adaptivealgorithm is suitably configured to receive two-dimensional imaging,temperature and/or treatment or other tissue parameter informationrelating to the region of interest, process the received information,and then provide corresponding three-dimensional imaging, temperatureand/or treatment information.

In accordance with an exemplary embodiment, with reference again to FIG.9, an exemplary three-dimensional system can comprise a two-dimensionalarray 900 configured with an adaptive algorithm to suitably receive 904slices from different image planes of the treatment region, process thereceived information, and then provide volumetric information 906, e.g.,three-dimensional imaging, temperature and/or treatment information.Moreover, after processing the received information with the adaptivealgorithm, the two-dimensional array 900 may suitably providetherapeutic heating to the volumetric region 906 as desired.

In accordance with other exemplary embodiments, rather than utilizing anadaptive algorithm, such as three-dimensional software, to providethree-dimensional imaging and/or temperature information, an exemplarythree-dimensional system can comprise a single transducer 404 configuredwithin a probe arrangement to operate from various rotational and/ortranslational positions relative to a target region.

To further illustrate the various structures for transducer 404, withreference to FIG. 7, ultrasound therapy transducer 700 can be configuredfor a single focus, an array of foci, a locus of foci, a line focus,and/or diffraction patterns. Transducer 700 can also comprise singleelements, multiple elements, annular arrays, one-, two-, orthree-dimensional arrays, broadband transducers, and/or combinationsthereof, with or without lenses, acoustic components, and mechanicaland/or electronic focusing. Transducers configured as sphericallyfocused single elements 702, annular arrays 704, annular arrays withdamped regions 706, line focused single elements 708, 1-D linear arrays710, 1-D curvilinear arrays in concave or convex form, with or withoutelevation focusing 712, 2-D arrays 714, and 3-D spatial arrangements oftransducers may be used to perform therapy and/or imaging and acousticmonitoring functions. For any transducer configuration, focusing and/ordefocusing may be in one plane or two planes via mechanical focus 720,convex lens 722, concave lens 724, compound or multiple lenses 726,planar form 728, or stepped form, such as illustrated in FIG. 10F. Anytransducer or combination of transducers may be utilized for treatment.For example, an annular transducer may be used with an outer portiondedicated to therapy and the inner disk dedicated to broadband imagingwherein such imaging transducer and therapy transducer have differentacoustic lenses and design, such as illustrated in FIG. 10C-10F.

Moreover, such transduction elements 700 may comprise apiezoelectrically active material, such as lead zirconate titanate(PZT), or any other piezoelectrically active material, such as apiezoelectric ceramic, crystal, plastic, and/or composite materials, aswell as lithium niobate, lead titanate, barium titanate, and/or leadmetaniobate. Transduction elements 700 may also comprise one or morematching layers configured along with the piezoelectrically activematerial. In addition to or instead of piezoelectrically activematerial, transduction elements 700 can comprise any other materialsconfigured for generating radiation and/or acoustical energy. A means oftransferring energy to and from the transducer to the region of interestis provided.

In accordance with another exemplary embodiment, with reference to FIG.12, an exemplary treatment system 200 can be configured with and/orcombined with various auxiliary systems to provide additional functions.For example, an exemplary treatment system 1200 for treatment of sweatglands can comprise a control system 1206, a probe 1204, and a display1208. For example, an exemplary treatment system 1200 for treatment ofsweat glands can further comprise an auxiliary imaging subsystem 1272and/or auxiliary monitoring modality 1274 may be based upon at least oneof photography and other visual optical methods, magnetic resonanceimaging (MRI), computed tomography (CT), optical coherence tomography(OCT), electromagnetic, microwave, or radio frequency (RF) methods,positron emission tomography (PET), infrared, ultrasound, acoustic, orany other suitable method of visualization, localization, or monitoringof the region-of-interest 1202, including imaging/monitoringenhancements. Such imaging/monitoring enhancement for ultrasound imagingvia probe 1204 and control system 1206 can comprise M-mode, persistence,filtering, color, Doppler, and harmonic imaging among others;furthermore an ultrasound treatment system 1270, as a primary source oftreatment, may be combined with a secondary treatment subsystem 1276,including radio frequency (RF), intense pulsed light (IPL), laser,infrared laser, microwave, or any other suitable energy source.

In accordance with another exemplary embodiment, with reference to FIG.13, treatment composed of imaging, monitoring, and/or therapy to aregion of interest 1302 and/or 1308 may be aided, augmented, and/ordelivered with passive or active devices 1304 and/or 1306 within theoral and/or nasal cavity, respectively. For example, if passive oractive device 1304 and/or 1306 are second transducers or acousticreflectors acoustically coupled to the mucous membranes it is possibleto obtain through transmission, tomographic, or round-trip acousticwaves which are useful for treatment monitoring, such as in measuringacoustic speed of sound and attenuation, which are temperaturedependent; furthermore such transducers could be used to treat and/orimage. In addition an active, passive, or active/passive object 1304and/or 1306 may be used to flatten the skin, and/or may be used as animaging grid, marker, or beacon, to aid determination of position. Apassive or active device 1304 and/or 1306 may also be used to aidcooling or temperature control. Natural air in the oral cavity and/ornasal cavity may also be used as passive device 1304 and/or 1306 wherebyit may be utilized to as an acoustic reflector to aid thicknessmeasurement and monitoring function.

The present invention may be described herein in terms of variousfunctional components and processing steps. It should be appreciatedthat such components and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,the present invention may employ various medical treatment devices,visual imaging and display devices, input terminals and the like, whichmay carry out a variety of functions under the control of one or morecontrol systems or other control devices. In addition, the presentinvention may be practiced in any number of medical contexts and thatthe exemplary embodiments relating to a system as described herein aremerely indicative of exemplary applications for the invention. Forexample, the principles, features and methods discussed may be appliedto any medical application. Further, various aspects of the presentinvention may be suitably applied to other applications, such as othermedical or industrial applications.

What is claimed is:
 1. An ultrasound treatment system configured fortreatment of sweat glands, said ultrasound treatment system comprising:a control system for facilitating control of the ultrasound treatmentsystem; and a probe system configured for targeted delivery ofultrasound energy to produce a treatment region for destroying saidsweat gland.